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Background: Chronically medically ill patients often need clinical assistance with symptom management, as well as self-care interventions that can help to reduce the impact of bothersome symptoms. Experienced clinicians can help to guide the development of more effective self-care interventions. Objective: To create a consensus-based list of common bothersome symptoms of chronic conditions and of self-care management behaviors recommended to patients by clinicians to reduce the impact of these symptoms. Methods: A two-round Delphi study was performed among an international panel of 47 clinicians using online surveys to identify common and bothersome symptoms and related self-care management behaviors recommended to patients with heart failure, chronic obstructive pulmonary disease, asthma, type 2 diabetes, or arthritis. Results: A total of 30 common bothersome symptoms and 158 self-care management behaviors across the five conditions were listed. Each chronic condition has its own bothersome symptoms and self-care management behaviors. Consensus was reached on the vast majority of recommended behaviors. Conclusions: The list of common bothersome symptoms and self-care management behaviors reflect consensus across four countries on many points but also disagreement on others, and a few recommendations are inconsistent with current guidelines. Efforts to encourage clinicians to recommend effective self-care management behaviors may reduce symptom impact in chronically ill patient populations.(C) 2022 The Author(s). Published by Elsevier Inc. Funding Agencies|Australian Catholic University, Australia

Background Anxiety and depression are common among older adults and can intensify during perioperative periods, but few mental health interventions are designed for older surgical patients’ unique needs. We developed and adapted a perioperative mental health (PMH) bundle for older patients comprised of behavioral activation (BA) and medication optimization (MO) to ameliorate anxiety and depressive symptoms before, during, and after cardiac, orthopedic, and oncologic surgery. Methods We used mixed-methods including workshop studios with patients, caregivers, clinicians, researchers, and interventionists; intervention refinement and reflection meetings; patient case review meetings; intervention session audio-recordings and documentation forms; and patient and caregiver semi-structured interviews. We used the results to refine our PMH bundle. We used multiple analytical approaches to report the nature of adaptations, including hybrid thematic analysis and content analysis informed by the Framework for Reporting Adaptations and Modifications – Expanded. Results Adaptations were categorized by content (intervention components), context (how the intervention is delivered, based on the study, target population, intervention format, intervention delivery mode, study setting, study personnel), training, and evaluation. Of 51 adaptations, 43.1% involved content, 41.2% involved context, and 15.7% involved training and evaluation. Several key adaptations were noted: 1) Intervention content was tailored to patient preferences and needs (e.g., rewording elements to prevent stigmatization of mental health needs; adjusting BA techniques and documentation forms to improve patient buy-in and motivation). 2) Cohort-specific adaptations were recommended based on differing patient needs. 3) Compassion was identified by patients as the most important element. Conclusions We identified evidence-based mental health intervention components from other settings and adapted them to the perioperative setting for older adults. Informed by mixed-methods, we created an innovative and pragmatic patient-centered intervention bundle that is acceptable, feasible, and responsive to the needs of older surgical populations. This approach allowed us to identify implementation strategies to improve the reach, scalability, and sustainability of our bundle, and can guide future patient-centered intervention adaptations.

Background: Major depression and inadequate self-care are common in patients with heart failure (HF). Little is known about how to intervene when both problems are present. This study examined the efficacy of a sequential approach to treating these problems. Methods: Stepped Care for Depression in HF was a single-site, single-blind, randomized controlled trial of cognitive behavior therapy (CBT) versus usual care (UC) for major depression in patients with HF. The intensive phase of the CBT intervention lasted between 8 and 16 weeks, depending upon the rate of improvement in depression. All participants received a tailored HF self-care intervention that began 8 weeks after randomization. The intensive phase of the self-care intervention ended at 16 weeks post-randomization. The coprimary outcome measures were the Beck Depression Inventory (version 2) and the Maintenance scale of the Self-Care of HF Index (v6.2) at week 16. Results: One hundred thirty-nine patients with HF and major depression were enrolled; 70 were randomized to UC and 69 to CBT. At week 16, the patients in the CBT arm scored 4.0 points ([95% CI, −7.3 to −0.8]; P =0.02) lower on the Beck Depression Inventory, version 2 than those in the usual care arm. Mean scores on the Self-Care of HF Index Maintenance scale were not significantly different between the groups ([95% CI, −6.5 to 1.5]; P =0.22). Conclusions: CBT is more effective than usual care for major depression in patients with HF. However, initiating CBT before starting a tailored HF self-care intervention does not increase the benefit of the self-care intervention. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02997865.

OBJECTIVE: Depression is common in patients with coronary artery disease (CAD) and is associated with poor outcomes. Although different treatments are available, it is unclear which are best or most acceptable to patients, so we conducted a network meta-analysis of evidence from randomized controlled trials (RCTs) of different depression treatments to ascertain relative efficacy.METHODS: We searched for systematic reviews of RCTs of depression treatments in CAD and updated these with a comprehensive search for recent individual RCTs. RCTs comparing depression treatments (pharmacological, psychotherapeutic, combined pharmacological/psychotherapeutic, exercise, collaborative care) were included. Primary outcomes were acceptability (dropout rate) and change in depressive symptoms 8 week after treatment commencement. Change in 26-week depression and mortality were secondary outcomes. Frequentist, random-effects network meta-analysis was used to synthesize the evidence, and evidence quality was evaluated following Grading of Recommendations, Assessment, Development and Evaluations recommendations.RESULTS: Thirty-three RCTs (7240 participants) provided analyzable data. All treatments were equally acceptable. At 8 weeks, combination therapy (1 study), exercise (1 study), and antidepressants (10 studies) yielded the strongest effects versus comparators. At 26 weeks, antidepressants were consistently effective, but psychotherapy was only effective versus usual care. There were no differences in treatment groups for mortality. Grading of Recommendations, Assessment, Development and Evaluations ratings ranged from very low to low.CONCLUSIONS: Overall, the evidence was limited and biased. Although all treatments for post-CAD depression were equally acceptable, antidepressants have the most robust evidence base and should be the first-line treatment. Combinations of antidepressants and psychotherapy, along with exercise, could be more effective than antidepressants alone but require further rigorous, multiarm intervention trials.Systematic Review Registration: CRD42018108293 (International Prospective Register of Systematic Reviews).

This Viewpoint examines the scarcity of psychiatric success rate trend data and discusses what can be done about it.

Objective This study examined whether the severity of left ventricular systolic dysfunction is associated with depression in patients with heart failure (HF). Other factors were also studied to identify independent correlates of depression in HF. Methods The sample consisted of 400 hospitalized patients with HF. Left ventricular ejection fraction and other medical data were obtained from medical records. Depression and other psychosocial characteristics were assessed by an interview and questionnaires. Proportional odds models were used to test the relationships of these characteristics to Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) depressive disorders, and analysis of covariance was used to test relationships with continuous measures of depression in secondary models. Results The models produced no evidence of an association between left ventricular ejection fraction and depression. The adjusted odds ratio (95% confidence interval) was 1.00 (0.98-1.01; p = .87) for depression diagnosis. Analysis of covariance estimates (standard errors) were -0.01 (0.02; p = .54) for the Hamilton Rating Scale for Depression and -0.01 (0.01; p = .59) for the Patient Health Questionnaire. The odds of depression were higher in African American patients and in those with high levels of anxiety or stress. Other characteristics that have been associated with depression in previous studies, including sex and age, were not consistently associated with depression in this study. Conclusions There is no relationship between the severity of left ventricular systolic dysfunction and depression in hospitalized patients with HF. In contrast, African American patients and those with a high level of anxiety or perceived stress are more likely than other patients to have a comorbid depressive disorder.

Symptoms which commonly remain after treatment for major depression increase the risk of relapse and recurrence in medically well patients. The same symptoms predict major adverse cardiac events in observational studies of patients with coronary heart disease (CHD). The purpose of this study was to determine the prevalence and predictors of residual depression symptoms in depressed patients with CHD-.Beck Depression Inventory-II data from two randomized clinical trials and an uncontrolled treatment study of depression in patients with CHD were combined to determine the prevalence and predictors of residual symptoms.Loss of energy, loss of pleasure, loss of interest, fatigue, and difficulty concentrating were the five most common residual symptoms in all three studies. They are also among the most common residual symptoms in medically well patients who are treated for depression. The severity of pre-treatment anxiety predicted the post-treatment persistence of all these symptoms except for loss of energy.The most common post-treatment residual symptoms found in this study of patients with coronary heart disease and comorbid major depression are the same as those that have been reported in previous studies of medically-well depressed patients. This suggests that they may be resistant to standard depression treatments across diverse patient populations. More effective treatments for these symptoms are needed.

Purpose-guided trial design (PGTD) is a novel heuristic framework for planning randomized controlled trials of health-related behavioral interventions. Its use helps to ensure that the study design and the control or comparison group are compatible with the primary purpose of the trial. When used in conjunction with the recently developed pragmatic model for comparator selection in health-related behavioral trials (Freedland et al., 2019), the PGTD framework can help to resolve uncertainties, disagreements, and controversies about the comparators that are used in behavioral randomized controlled trials. For example, PGTD can help to answer questions about whether, when, and how to control for attention in behavioral trials. The PGTD framework can be used to evaluate published trials, but it is primarily intended for use as a behavioral trial planning tool. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Psychological resilience represents an important construct for physical and behavioral health. This article introduces a special section on resilience as it relates to health psychology. In this special section, resilience in the context of cardiovascular disease, neurological disorders, sleep disorders, and cancers are studied. This special section is part of an American Psychological Association (APA) interdivisional journal series on resilience. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

This study examined how certain aspects of residential neighborhood conditions (ie, observed built environment, census-based area-level poverty, and perceived disorder) affect readmission in urban patients with heart failure.A total of 400 patients with heart failure who were discharged alive from an urban-university teaching hospital were enrolled. Data were collected about readmissions during a 2-year follow-up. The impact of residential neighborhood conditions on readmissions was examined with adjustment for 7 blocks of covariates: 1) patient demographic characteristics; 2) comorbidities; 3) clinical characteristics; 4) depression; 5) perceived stress; 6) health behaviors; and 7) hospitalization characteristics.A total of 83.3% of participants were readmitted. Participants from high-poverty census tracts (≥20%) were at increased risk of readmission compared with those from census tracts with10% poverty (hazard ratio [HR]: 1.53; 95% confidence interval: 1.03-2.27; P.05) when adjusted for demographic characteristics. None of the built environmental or perceived neighborhood conditions were associated with the risk of readmission. The poverty-related risk of readmission was reduced to nonsignificance after including diabetes (HR: 1.33) and hypertension (HR: 1.35) in the models.The effect of high poverty is partly explained by high rates of hypertension and diabetes in these areas. Improving diabetes and blood pressure control or structural aspects of impoverished areas may help reduce hospital readmissions.

The impetus for the special issue, "From Ideas to Efficacy" was the perceived need to stimulate and support a more vibrant research base that translates basic behavioral and social science research (bBSSR) discoveries to clinical and public health interventions. This special issue presents novel research that advances translational behavioral science, focusing primarily on the early phases of behavioral translation that are not as well recognized as later-phase translational science (e.g., dissemination and implementation research). The special issue includes a series of empirical, conceptual, and methodological papers, and a shining example of translational research that has had important clinical implications for the treatment of obesity and prevention of people with prediabetes from transitioning to Type II diabetes. In this introduction we will first set the context of the special issue and briefly comment on the papers. We end with several ideas in the areas of funding, training and publication of early phase translational behavioral science that can accelerate the process through which new ideas from our deepening understanding of human behavior can be more rapidly and fully brought to bear on the pressing health problems facing our nation and our world. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Preparation of this manuscript was supported in part by grant number R01HL089336 from the National Heart, Lung, and Blood Institute of the National Institutes of Health, Bethesda, Maryland USA, Robert M. Carney.

Purpose of review Heart failure has substantial effects on health-related quality of life. Maintaining or improving quality of life is an important goal of heart failure therapy, and many patients value better quality of life over greater longevity. Recent findings The symptoms and functional severity of heart failure, medical comorbidities, and depression are the strongest predictors of poor quality of life. Guideline-recommended medical and behavioral interventions for HF, including exercise training and cardiac rehabilitation, self-care interventions, and treatment of depression, can help to improve quality of life. Heart failure is, in most cases, a progressive condition with a poor prognosis. However, poor quality of life is not inevitable, and a variety of medical, surgical, and nonpharmacological interventions can help to maintain or improve quality of life in patients with heart failure.

BackgroundDecisions about how to manage bothersome symptoms of chronic illness are complex and influenced by factors related to the patient, their illness, and their environment. Naturalistic decision-making describes decision-making when conditions are dynamically evolving, and the decision maker may be uncertain because the situation is ambiguous and missing information. Contextual factors, including time stress, the perception of high stakes, and input from others may facilitate or complicate decisions about the self-care of symptoms. There is no valid instrument to measure these contextual factors. The purpose of this study was to develop and test a self-report instrument measuring the contextual factors that influence self-care decisions about symptoms.MethodsItems were drafted from the literature and refined with patient input. Content validity of the instrument was evaluated using a Delphi survey of expert clinicians and researchers, and cognitive interviews with adults with chronic illness. Psychometric testing included exploratory factor analysis to test dimensionality, item response theory-based approaches for item recalibration, confirmatory factor analysis to generate factor determinacy scores, and evaluation of construct validity.ResultsTen contextual factors influencing decision-making were identified and multiple items per factor were generated. Items were refined based on cognitive interviews with five adults with chronic illness. After a two round Delphi survey of expert clinicians (n = 12) all items had a content validity index of > 0.78. Five additional adults with chronic illness endorsed the relevance, comprehensiveness, and comprehensibility of the inventory during cognitive interviews. Initial psychometric testing (n = 431) revealed a 6-factor multidimensional structure that was further refined for precision, and high multidimensional reliability (0.864). In construct validity testing, there were modest associations with some scales of the Melbourne Decision Making Questionnaire and the Self-Care of Chronic Illness Inventory.ConclusionThe Self-Care Decisions Inventory is a 27-item self-report instrument that measures the extent to which contextual factors influence decisions about symptoms of chronic illness. The six scales (external, urgency, uncertainty, cognitive/affective, waiting/cue competition, and concealment) reflect naturalistic decision making, have excellent content validity, and demonstrate high multidimensional reliability. Additional testing of the instrument is needed to evaluate clinical utility.

Heart failure has substantial effects on health-related quality of life. Maintaining or improving quality of life is an important goal of heart failure therapy, and many patients value better quality of life over greater longevity.The symptoms and functional severity of heart failure, medical comorbidities, and depression are the strongest predictors of poor quality of life. Guideline-recommended medical and behavioral interventions for HF, including exercise training and cardiac rehabilitation, self-care interventions, and treatment of depression, can help to improve quality of life. Heart failure is, in most cases, a progressive condition with a poor prognosis. However, poor quality of life is not inevitable, and a variety of medical, surgical, and nonpharmacological interventions can help to maintain or improve quality of life in patients with heart failure.

Depression increases the risk of mortality in patients with heart failure (HF). Less is known about whether depression predicts multiple readmissions or whether multiple hospitalizations worsen depression in patients with HF. This study aimed to test the hypotheses that depression predicts multiple readmissions in patients hospitalized with HF, and conversely that multiple readmissions predict persistent or worsening depression. All-cause readmissions were ascertained over a 2-year follow-up of a cohort of 400 patients hospitalized with HF. The Patient Health Questionnaire-9 was used to assess depression at index and 3-month intervals. At enrollment in the study, 21% of the patients were mildly depressed and 22% were severely depressed. Higher Patient Health Questionnaire-9 depression scores predicted a higher rate of readmissions (adjusted hazard ratio 1.02, 95% confidence interval 1.00 to 1.04, p = 0.03). The readmission rate was higher in those who were severely depressed than in those without depression (p = 0.0003), but it did not differ between patients who were mildly depressed and patients without depression. Multiple readmissions did not predict persistent or worsening depression, but younger patients in higher New York Heart Association classes were more depressed than other patients. Depression is an independent risk factor for multiple all-cause readmissions in patients hospitalized with HF. Severe depression is a treatable psychiatric co-morbidity that warrants ongoing clinical attention in patients with HF.

OBJECTIVE Limited evidence is available to guide treatment of depression for persons with epilepsy. We evaluated the comparative effectiveness of sertraline and cognitive behavior therapy (CBT) for depression, quality of life, seizures, and adverse treatment effects. METHODS We randomly assigned 140 adult outpatients with epilepsy and current major depressive disorder to sertraline or weekly CBT for 16 weeks. The primary outcome was remission from depression based on the Mini International Neuropsychiatric Interview (MINI). Secondary outcomes included the Quality of Life in Epilepsy Inventory-89 (QOLIE-89) seizure rates, the Adverse Events Profile (AEP), the Beck Depression Inventory, and MINI Suicide Risk Module. RESULTS In the intention-to-treat analysis, 38 (52.8%; 95% confidence interval [CI] = ±12) of the 72 subjects assigned to sertraline and 41 (60.3%; 95% CI = ±11.6) of the 68 subjects in the CBT group achieved remission; the lower bound of efficacy for both groups was greater than our historical placebo control group upper bound of 33.7%. Difference in time to remission between groups was 2.8 days (95% CI = ±0.43; p = 0.79). The percent improvement of mean QOLIE-89 scores was significant for both the CBT (25.7%; p

Objectives To provide recommendations for the selection of comparators for randomized controlled trials of health-related behavioral interventions. Study Design and Setting The National Institutes of Health Office of Behavioral and Social Science Research convened an expert panel to critically review the literature on control or comparison groups for behavioral trials and to develop strategies for improving comparator choices and for resolving controversies and disagreements about comparators. Results The panel developed a Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials. The model indicates that the optimal comparator is the one that best serves the primary purpose of the trial but that the optimal comparator's limitations and barriers to its use must also be taken into account. Conclusion We developed best practice recommendations for the selection of comparators for health-related behavioral trials. Use of the Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials can improve the comparator selection process and help resolve disagreements about comparator choices.

Objective Although cognitive behavior therapy (CBT) is efficacious for major depression in patients with heart failure (HF), approximately half of patients do not remit after CBT. To identify treatment moderators that may help guide treatment allocation strategies and serve as new treatment targets, we performed a secondary analysis of a randomized clinical trial. Based on evidence of their prognostic relevance, we evaluated whether clinical and activity characteristics moderate the effects of CBT. Methods Participants were randomized to enhanced usual care (UC) alone or CBT plus enhanced UC. The single-blinded outcomes were 6-month changes in Beck Depression Inventory total scores and remission (defined as a Beck Depression Inventory ≤ 9). Actigraphy was used to assess daily physical activity patterns. We performed analyses to identify the specific activity and clinical moderators of the effects of CBT in 94 adults (mean age = 58, 49% female) with HF and major depressive disorder. Results Patients benefited more from CBT (versus UC) if they had the following: more medically severe HF (i.e., a higher New York Heart Association class or a lower left ventricular ejection fraction), more stable activity patterns, wider active periods, and later evening settling times. These individual moderator effects were small (|r| = 0.10-0.21), but combining the moderators yielded a medium moderator effect size (r = 0.38; 95% CI = 0.20-0.52). Conclusions These findings suggest that increasing the cross-daily stability of activity patterns, and prolonging the daily active period, might help increase the efficacy of CBT. Given moderating effects of HF severity measures, research is also needed to clarify and address factors in patients with less severe HF that diminish the efficacy of CBT. Clinical trial registration clinicaltrials.gov identifier: NCT01028625.

The Behavioral Medicine Research Council (BMRC) is a new, autonomous joint committee of 4 of the leading behavioral medicine research organizations, including the Academy of Behavioral Medicine Research, the American Psychosomatic Society, the Society for Health Psychology, and the Society of Behavioral Medicine. The BMRC's work has important implications for the science and practice of behavioral medicine. The distinguished senior scientists who comprise this new committee will identify a series of strategic research goals for behavioral medicine and promote systematic, interdisciplinary efforts to achieve them. This special report discusses the developments that led to the formation of the BMRC, describes the BMRC's mission, and explains the methods that its members will use. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

IntroductionThe perioperative period is high risk for older adults. Depression and anxiety are common perioperative problems, frequently coexisting with cognitive impairment. Older patients with these conditions are more likely than younger patients to experience postoperative delirium, long hospital stays, poor quality of life and rehospitalisation. These experiences can, in turn, exacerbate anxiety and depressive symptoms. Despite these risks, little is known about how to treat perioperative anxiety and depression among older adults.Methods and analysisWe designed a feasibility study of a perioperative mental health intervention bundle to improve perioperative mental health, specifically depression and anxiety. The overarching goals of this study are twofold: first, to adapt and refine an intervention bundle comprised of behavioural activation and medication optimisation to meet the needs of older adults within three surgical patient populations (ie, orthopaedic, oncological and cardiac); and second, to test the feasibility of study procedures and intervention bundle implementation. Quantitative data on clinical outcomes such as depression, anxiety, quality of life, delirium, falls, length of stay, hospitalisation and pain will be collected and tabulated for descriptive purposes. A hybrid inductive–deductive thematic approach will be employed to analyse qualitative feedback from key stakeholders.Ethics and disseminationThe study received approval from the Washington University Institutional Review Board. Results of this study will be presented in peer-reviewed journals, at professional conferences, and to our perioperative mental health advisory board.Trial registration numberNCT05110690.

Funding Acknowledgements Type of funding sources: None. Objective Depression is common in patients with coronary artery disease (CAD) and is associated with poor outcomes. Although different treatments are available, it is unclear which are best or most acceptable to patients, so we conducted a network meta-analysis of evidence from randomized controlled trials (RCTs) of different depression treatments to ascertain relative efficacy. Methods We searched for systematic reviews of RCTs of depression treatments in CAD and updated these with a comprehensive search for recent individual RCTs. RCTs comparing depression treatments (pharmacological, psychotherapeutic, combined pharmacological/psychotherapeutic, exercise, collaborative care) were included. Primary outcomes were acceptability (dropout rate) and change in depressive symptoms 8-weeks post-treatment commencement. Change in 26-week depression and mortality were secondary outcomes. Frequentist, random effects network meta-analysis synthesized the evidence. GRADE was used to assess evidence quality. Results Thirty-three RCTs (7240 participants) provided analysable data. All treatments were equally acceptable. At 8-weeks, combination therapy (1 study), exercise (1 study), and antidepressants (10 studies) yielded the strongest effects versus comparators. At 26-weeks, antidepressants were consistently effective, but psychotherapy was only effective versus usual care. There were no differences in treatment groups for mortality. GRADE ratings ranged from very low to low. Conclusions All treatments were equally acceptable, while antidepressants appeared to have the most robust evidence base for post-CAD depression. The evidence base was limited and biased; conclusions based on this literature should be drawn cautiously and considered to be tentative. Rigorous, multi-arm intervention trials, including trials of combination therapies and exercise, are urgently needed.

The Editors are pleased to announce that Health Psychology has adopted the Transparency and Openness Promotion (TOP) Guidelines (Center for Open Science, 2021). We and the other core American Psychological Association (APA) journals are implementing these guidelines at the direction of the APA Publications and Communications Board. Their decision was made with the support of the APA Council of Editors and the APA Open Science and Methodology Committee. The TOP Guidelines were originally published in Science (Nosek et al. 2015) to encourage journals to incentivize open research practices. They are being implemented by a wide range of scientific publications, including some of the leading behavioral and medical research journals. The TOP guidelines for Health Psychology are outlined in our recently revised Instructions to Authors. We are implementing most of the standards at TOP Level 1, which means that adherence is required. We are implementing other standards at Level 2, which means that authors are encouraged to adhere to them and required to disclose whether and how they have done so. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Existence of an alternative explanation for the benefit of a treatment is a confounder. It is a nuisance “passenger” variable that rides along with treatment and undermines the ability to make causal inferences. This chapter focuses on why random assignment is so powerful and should be protected. It presents a history of attempts to answer the question of whether or not a treatment works, and the arrival at random assignment as the best way to make causal inferences about the benefits of a treatment. It defines confounding as an error of interpretation and the essential role of avoiding it by protecting the random assignment. It then goes on to illustrate ways to protect random assignment in the design, conduct, and analyses of a trial, with particular attention to the central role of identifying a patient-centered target population, recruiting it, retaining it, and insuring that all randomized participants are included in the evaluation of trial results.

To close the gap between evidence-based behavioral treatments for chronic diseases and their uptake in clinical practice, this book aims to encourage the development of evidence for the value of behavioral treatments that meets the standards for quality that exist in medicine. Evidence for quality is strongest in Phase III efficacy trials which follow the agreed-upon “rules” for clinical trial methods. In the behavioral clinical trial literature, there are many more Phase II than Phase III trials. What is needed is not a larger quantity of such evidence, but a higher quality of evidence using the standards that exist in medicine. This book applies a progressive, translational science model to achieve that goal.

Background and objective: The beneficial effects of self-care include improved well-being and lower morbidity, mortality, and healthcare costs. In this article we address the current state of self-care research and propose an agenda for future research based on the inaugural conference of the International Center for Self-Care Research held in Rome, Italy in June 2019. The vision of this Center is a world where self-care is prioritized by individuals, families, and communities and is the first line of approach in every health care encounter. The mission of the Center is to lead the self-care research endeavor, improving conceptual clarity and promoting interdisciplinary work informed by a shared vision addressing knowledge gaps. A focused research agenda can deepen our theoretical understanding of self-care and the mechanisms underlying self-care, which can contribute to the development of effective interventions that improve outcomes. Methods: During conference discussions, we identified seven major reasons why self-care is challenging, which can be grouped into the general categories of behavior change and illness related factors. We identified six specific knowledge gaps that, if addressed, may help to address these challenges: the influence of habit formation on behavior change, resilience in the face of stressful life events that interfere with self-care, the influence of culture on self-care behavioral choices, the difficulty performing self-care with multiple chronic conditions, self-care in persons with severe mental illness, and the influence of others (care partners, family, peer supporters, and healthcare professionals) on self-care. Plans to achieve results: To achieve the vision and mission of the Center, we will lead a collaborative program of research that addresses self-care knowledge gaps and improves outcomes, create a supportive international network for knowledge transfer and support of innovations in self-care research, and support and train others in self-care research. Beyond these specific short-term goals, important policy implications of this work are discussed. (c) 2019 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ) Funding Agencies|Australian Catholic University; National Institutes of Health/National Institute for Nursing Research (NINR) [R01NR018196]; Swedish National Science Council/Swedish Research Council for Health, Working Life and Welfare (VR-FORTE); Center of Excellence for Nursing Scholarship

This chapter defines feasibility and pilot studies according to the 2010 CONSORT guidelines. Feasibility studies are always linked to a planned clinical trial. Pilot studies are a subset of feasibility studies that use an identical randomized design as the planned clinical trial but are conducted to answer questions about the feasibility of a protocol. Pilot studies are distinct from miniature efficacy trials. Although both are conducted on a small number of participants and use a randomized design, pilot studies focus on feasibility, but miniature efficacy trials claim to provide estimates of efficacy. The evolving literature on behavioral trial methodology has shown a variety of problems that result from estimating efficacy with underpowered miniature efficacy trials. Recommendations are to prepare for a definitive behavioral clinical trial by making a strong case for its credibility, plausibility, and feasibility and by estimating effect sizes using targets needed to achieve clinically significant benefit. The popular practice of conducting miniature efficacy trials which are loosely linked to a planned behavioral trial, calling them pilot studies, drawing conclusions about potential efficacy, and using results to estimate sample size should be discontinued.

This chapter proposes a progressive, translational model for developing behavioral treatments for chronic diseases. It begins by describing the long-standing, evolving, and widely accepted process of drug development. It then draws on basic elements of this process to present the revised ORBIT model for developing behavioral treatments for chronic diseases. This model pushes toward Phase III behavioral efficacy testing in three progressive phases: (1) Discovery of an important clinical problem and a basic science underpinning for a behavioral treatment that could solve it; (2) Design of the treatment by first assembling basic elements and then refining them to enhance efficiency without sacrificing efficacy; and (3) Preliminary Testing of a fixed protocol using proof-of-concept studies, feasibility studies, and Phase II behavioral trials with behavioral and biomedical outcomes. Recommendations for fostering translational behavioral treatment research are suggested for funding agencies, publication practices, and investigators.

Background: Theories can provide a foundation to explain behavior, investigate relationships, and to predict the effect of interventions. The aim of the study was to clarify the use of theories in studies testing interventions to promote self-care. Method: A scoping review. PubMed, EMBASE, PsychINFO, and CINAHL were searched from January 2008 through January 2019. Nine common chronic conditions were included. We included studies testing a self-care intervention if they used a randomized controlled trial design. The study was registered in PROSPERO (#123719). Results: The search retrieved 9309 potential studies, of which 233 were included in the review. In total, 76 (33%) of the 233 studies used a theory and 24 different theories were used. Banduras social cognitive theory was the most frequently used (48 studies), but 22 other theories were used in a minority of studies. Most studies used theories minimally to justify or provide a rationale for the study, to develop the intervention, to select outcomes, and/or to explain the results. Only eight studies fully used a theory in the rationale, intervention development, choice of outcomes, and discussion. Conclusion: The use of theories to guide self-care research is limited, which may pose a barrier in accumulating knowledge underlying self-care interventions. Funding Agencies|Australian Catholic University; National Institutes of Health/National Institute for Nursing Research (NINR) [R01NR018196]; Swedish National Science Council/Swedish Research Council for Health, Working Life and Welfare (VR-FORTE); Center of Excellence for Nursing Scholarship; Linkoping University

Health Psychology has received numerous papers over the past several months on topics related to the COVID-19 pandemic. Many of them concern depression, anxiety, stress, or other forms of distress in the general population or in health care workers. We have received far fewer papers on COVID-related health behaviors and health communications-factors that have played central roles in the spread of the pandemic and that are major topics in health psychology. Our experience is consistent with the published scientific literature on the pandemic. A Medline search that we conducted in late September yielded over 23,000 English-language articles pertaining to COVID-19. Over 1,400 of them concerned topics that are within the scope of Health Psychology. As shown in Table 1, COVID-related mental disorders comprised the largest category. Many other studies concerned other forms of stress or emotional distress. At least 248 articles addressed the profound ethnic and racial disparities in COVID-19 infection and death rates and in access to health care that are accentuating longstanding health inequities; 22 (9%) of these articles addressed behavioral or psychosocial aspects of COVID-19 health disparities. Thus, the literature on the behavioral and psychosocial aspects of the pandemic has been dominated, so far at least, by research on stress or distress. Fewer reports have been published so far on critical COVID-related health behaviors, health communication, or health disparities. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

The goal of precision medicine (individually tailored treatments) is not being achieved for neurobehavioural conditions such as psychiatric disorders. Traditional randomized clinical trial methods are insufficient for advancing precision medicine because of the dynamic complexity of these conditions. We present a pragmatic solution: the precision clinical trial framework, encompassing methods for individually tailored treatments. This framework includes the following: (1) treatment-targeted enrichment, which involves measuring patients' response after a brief bout of an intervention, and then randomizing patients to a full course of treatment, using the acute response to predict long-term outcomes; (2) adaptive treatments, which involve adjusting treatment parameters during the trial to individually optimize the treatment; and (3) precise measurement, which involves measuring predictor and outcome variables with high accuracy and reliability using techniques such as ecological momentary assessment. This review summarizes precision clinical trials and provides a research agenda, including new biomarkers such as precision neuroimaging, transcranial magnetic stimulation-electroencephalogram digital phenotyping and advances in statistical and machine-learning models. Validation of these approaches - and then widespread incorporation of the precision clinical trial framework - could help achieve the vision of precision medicine for neurobehavioural conditions.

Depression has been identified as a barrier to effective heart failure self-care, but recent studies suggest that the relationship between depression and self-care is more complex than was previously believed. This study was designed to clarify the relationship between depression and self-care in hospitalized patients with HF.During hospitalization with a confirmed clinical diagnosis of HF, 400 patients completed a structured interview to diagnose Diagnostic and Statistical Manual, 5th edition (DSM-5) depressive disorders, the Patient Health Questionnaire (PHQ-9) depression questionnaire, the Self-Care of Heart Failure Index (SCHFI), and several psychosocial questionnaires. Multivariable models were fitted to each SCHFI scale; separate models were run with DSM-5 disorders and PHQ-9 depression scores. Higher PHQ-9 depression scores were independently associated with lower (worse) scores on the SCHFI Maintenance (P.05), Management (P.01), and Confidence (P.01) scales. No independent associations with DSM-5 depressive disorders were detected. Measures of perceived stress, anxiety, and low perceived social support were also significantly associated with poor HF self-care.Patients with a combination of psychosocial problems, including symptoms of depression, stress, anxiety, and inadequate social support, may be more likely than other patients to display difficulties with HF self-care that can increase their risk for hospitalization. Research is needed on "broad-spectrum" psychosocial interventions for patients with HF self-care deficits.

Pilot studies can help to pave the way for larger randomized controlled trials of health-related behavioral interventions. Unfortunately, there is widespread uncertainty and confusion about the kinds of studies that should or should not be called pilot trials, and about their relationship to other types of preliminary studies of behavioral interventions. The traditional conceptualization of pilot studies as "preliminary efficacy" trials has been especially problematic. This report identifies some common and problematic weaknesses in pilot trials. It also describes a strategy for preliminary research on behavioral interventions that can prevent these problems, and provides recommendations for researchers and reviewers. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Background and objective The number of studies in the area of self-care is growing and international researchers are increasingly developing self-care interventions to improve outcomes of individual patients and communities. However, growth of the evidence is still slow due to challenges with designing and testing self-care interventions. In this article we address major methodological challenges with regard to the definition of self-care, use of theory, and research design, intended to provide guidance to researchers in this field. Method During the inaugural conference of the International Center for Self-Care Research held in Rome, Italy in June 2019 we identified important issues in existing self-care research. Discussion and literature review lead to eight recommendation for future self-care research. Results In preparation, begin with a theoretically sound definition of self-care. In planning the intervention, build on and extend previous studies. Use theory to develop self-care interventions and consider translational models to guide development, evaluation and implementation of complex self-care interventions. Employ a study design that fits the current phase and objectives of the research and measure self-care and related factors carefully. In reporting, describe the sample and setting sufficiently so that others can draw conclusions about generalizability and applicability to their practice and patient population. In interpretation, describe how the intervention is assumed to work (causal assumptions) and its key components. Conclusion Our review of existing self-care research clearly illustrates that the recommendations we provide are needed if we are to substantially grow the evidence base supporting self-care. Embracing a core set of principles will allow us to build on each other's work. Tweetable abstract: A core set of methodological principles is needed to substantially grow the evidence base supporting self-care.

Clinical depression in children as young as age 3 has been validated, and prevalence rates are similar to the school-age disorder. Homotypic continuity between early and later childhood depression has been observed, with alterations in brain function and structure similar to those reported in depressed adults. These findings highlight the importance of identifying and treating depression as early as developmentally possible, given the relative treatment resistance and small effect sizes for treatments later in life. The authors conducted a randomized controlled trial of a dyadic parent-child psycho-therapy for early childhood depression that focuses on enhancing the child's emotional competence and emotion regulation.A modified version of the empirically tested parent-child interaction therapy with a novel "emotion development" module (PCIT-ED) was compared with a waiting list condition in a randomized controlled trial in 229 parent-child dyads with children 3-6.11 years of age. Both study arms lasted 18 weeks.Children in the PCIT-ED group had lower rates of depression (primary outcome), lower depression severity, and lower impairment compared with those in the waiting list condition (Cohen's d values,1.0). Measures of child emotional functioning and parenting stress and depression were significantly improved in the PCIT-ED group.The findings from this randomized controlled trial of a parent-child psychotherapy for early childhood depression suggest that earlier identification and intervention in this chronic and relapsing disorder represents a key new pathway for more effective treatment. Manualized PCIT-ED, administered by master's-level clinicians, is feasible for delivery in community health settings.

This editorial discusses the new vision and rejuvenation for the journal of Health Psychology. (PsycINFO Database Record